Status:

COMPLETED

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Pneumococcal Infections

Eligibility:

All Genders

42-72 years

Phase:

PHASE3

Brief Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with ro...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Healthy infants aged 6 weeks (42-72 days) at time of enrolment
  • Available for the entire study period
  • Exclusion Criteria
  • Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines
  • A previous anaphylactic reaction to any vaccine or vaccine-related component
  • Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines

Exclusion

    Key Trial Info

    Start Date :

    June 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2010

    Estimated Enrollment :

    708 Patients enrolled

    Trial Details

    Trial ID

    NCT00452790

    Start Date

    June 1 2007

    End Date

    February 1 2010

    Last Update

    March 24 2011

    Active Locations (12)

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    Page 1 of 3 (12 locations)

    1

    Sector-12, Chandigarh, India, 160 012

    2

    Sector-32 B, Chandigarh, India, 160031

    3

    Bangalore, Karnataka, India, 560 034

    4

    Bangalore, Karnataka, India, 560017